NATURAL HERBAL COFFEE AMPT recalled over undeclared milk

Recall date

August 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Ampt Life, LLC recalls NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufact…

Recall number

D-0126-2018

FDA classification

Class I

Brand / firm

The Ampt Life, LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil and tadalafil and undeclared milk. The presence of sildenafil and tadalafil makes AMPT Natural Herbal Coffee an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. Additionally, this product has been found to contain undeclared milk, milk is recognized as one of the foods reported to have caused deaths due to anaphylactic shock in persons with underlying hypersensitivities.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

NATURAL HERBAL COFFEE AMPT, sold in 25g packages (UPC 6942630905), 10-count packages per box (UPC 6942630912); Manufactured For: The Ampt Life, LLC.